PROJECT SUMMARY In the US, tens of thousands of children, adolescents, and young adults (AYA) are estimated to live with severe neurologic impairment (SNI), a condition that poses an unequal burden on families from minority and low-income backgrounds. Over 60% of these children suffer from uncontrolled pain, which is often persistent, unrecognized, and untreated. The impact extends to their parents who commonly experience unremitting physical and psychological distress. There have been no rigorous intervention studies aimed at treating recurrent pain in children with SNI. This gap may exist because children with SNI are stigmatized and often from historically marginalized backgrounds, and not prioritized in scientific research. To address this inequity and using the ORBIT Model for intervention development, the research team has adapted and refined an intervention previously applied in children with cancer. The PediQUEST Response to Pain Of children with Neurologic Disability (PQ-ResPOND) uses “reciprocal activation” strategies to overcome normalization, the acceptance among parents and clinicians that symptom distress is an unavoidable outcome of serious illness and integration of a specialty pediatric palliative care team (PPC) to respond to child distress. Specifically, PQ-ResPOND will combine (i) parent-mediated activation through weekly collection and feedback to parents and clinicians, via our PQ App, of parent reported child pain (Non-Communicating Children’s Pain Checklist-Revised scale (NCCPC-R)) and other symptoms (PediQUEST-Memorial Symptom Assessment Scale adapted for children with SNI), with (ii) PPC team activation of primary clinicians: through consultation by PPC, and (iii) PPC team activation through training in a standardize recurrent pain approach using the PQ-ResPOND Checklist (adapted by the study’s interprofessional expert panel).The overall hypothesis is that PQ-ResPOND will improve child recurrent pain, and parent distress, burden, and activation. The overall objective of this R21 proposal is to conduct a single site Phase II Pilot Feasibility 2:1 RCT of PQ-ResPOND (intervention, n=30) vs. usual care (control, n=15) in 45 children ≥1 year-old & AYA with SNI and recurrent pain behaviors. A 2-week run-in period will exclude children with mild pain and survey non-responders. Parents of children who meet randomization criteria will answer weekly PQ- ResPOND surveys and monthly outcome surveys over 12 weeks via the PQ App, and a semi-structured exit interview. Specific Aims are to 1. assess the study’s feasibility (>60% enrollment rate and >80% retention), intervention acceptability (>70% parents would recommend the intervention and most parents and clinicians provide positive feedback during qualitative exit interviews), and estimate monthly enrollment rate; and 2. Estimate effect sizes and variability of the proposed trial outcomes: child pain, parent distress and burden (anxiety, depression, stress, burden, overall health, and sleep quality), and parent activation (use of complementary therapies and coping). Results will inform the study design and sample size calculation of a larger Phase III Efficacy trial, development of a manual of procedures and fidelity monitoring strategies. The interprofessional research team has the expertise to expand and test this PPC intervention to ease pain in children with SNI, a novel population that is marginalized, stigmatized, and understudied.

PROJECT NARRATIVE About 90,000 US children, adolescents, and young adults live with a severe neurologic impairment; these children are typically marginalized and understudied, and a majority suffer from uncontrolled pain. Using a rigorous research approach, we propose to pilot test the PediQUEST ResPOND intervention, which combines the use of electronic parent reported outcome measures with integration of a specialized pediatric palliative care team to systematically address pain and distress in these underserved children and their parents that, if successful, will lead to a multisite Phase III trial. The proposal ultimately aims to improve quality of life and promote health equity and access in children with severe neurologic impairment and their parents, which is aligned with top priorities of the National Institute of Nursing Research, National Academy of Medicine, and World Health Organization.